Optimising corticosteroid injection for lateral epicondylalgia with the addition of physiotherapy: A protocol for a randomised control trial with placebo comparison

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Title Optimising corticosteroid injection for lateral epicondylalgia with the addition of physiotherapy: A protocol for a randomised control trial with placebo comparison
Author Coombes, Brooke K; Bisset, Leanne Margaret; Connelly, Luke B; Brooks, Peter; Vicenzino, Bill
Journal Name BMC Musculoskeletal Disorders
Year Published 2009
Place of publication United Kingdom
Publisher BioMed Central Ltd
Abstract Background: Corticosteroid injection and physiotherapy are two commonly prescribed interventions for management of lateral epicondylalgia. Corticosteroid injections are the most clinically efficacious in the short term but are associated with high recurrence rates and delayed recovery, while physiotherapy is similar to injections at 6 weeks but with significantly lower recurrence rates. Whilst practitioners frequently recommend combining physiotherapy and injection to overcome harmful effects and improve outcomes, study of the benefits of this combination of treatments is lacking. Clinicians are also faced with the paradox that the powerful anti-inflammatory corticosteroid injections work well, albeit in the short term, for a noninflammatory condition like lateral epicondylalgia. Surprisingly, these injections have not been rigorously tested against placebo injections. This study primarily addresses both of these issues. Methods: A randomised placebo-controlled clinical trial with a 2 × 2 factorial design will evaluate the clinical efficacy, costeffectiveness and recurrence rates of adding physiotherapy to an injection. In addition, the clinical efficacy and adverse effects of corticosteroid injection beyond that of a placebo saline injection will be studied. 132 participants with a diagnosis of lateral epicondylalgia will be randomly assigned by concealed allocation to one of four treatment groups – corticosteroid injection, saline injection, corticosteroid injection with physiotherapy or saline injection with physiotherapy. Physiotherapy will comprise 8 sessions of elbow manipulation and exercise over an 8 week period. Blinded follow-up assessments will be conducted at baseline, 4, 8, 12, 26 and 52 weeks after randomisation. The primary outcome will be a participant rating of global improvement, from which measures of success and recurrence will be derived. Analyses will be conducted on an intention-to-treat basis using linear mixed and logistic regression models. Healthcare costs will be collected from a societal perspective, and along with willingness-to-pay and quality of life data will facilitate cost-effectiveness and cost-benefit analyses. Conclusion: This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. Findings from this study will assist in the development of evidence based practice recommendations and potentially the optimisation of resource allocation for rehabilitating lateral epicondylalgia. Trial registration: Australian New Zealand Clinical Trials Register ACTRN12609000051246
Peer Reviewed Yes
Published Yes
Alternative URI http://dx.doi.org/10.1186/1471-2474-10-76
Copyright Statement Copyright 2009 Coombs et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Volume 10
Page from 1
Page to 11
ISSN 1471-2474
Date Accessioned 2010-03-04
Language en_AU
Comments Page numbers are not for citation purposes. Instead, this article has the unique article number of 10:76.
Research Centre Griffith Health Institute; Centre for Musculoskeletal Research
Faculty Griffith Health Faculty
Subject Medical and Health Sciences
URI http://hdl.handle.net/10072/29878
Publication Type Journal Articles (Refereed Article)
Publication Type Code c1

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